A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose Safety Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Treatment-related Adverse Events
研究概览
简要总结
A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females between 18 and 55 years (inclusive) of age.
- •Non-smoking (by declaration) for a period of at least 6 months.
- •Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Haematology and Chemistry values within normal ranges or with no clinical significance
- •Subjects who provide written informed consent to participate in the study
排除标准
- •Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
- •Ongoing flu symptoms or influenza
- •Any clinically significant abnormality upon physical examination or in the clinical laboratory test at screening visit.
- •Treatment with immune immunosuppressant drugs or other immune enhancing drugs.
- •Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within one year prior to the screening visit.
- •Administration of any vaccine 30 days before the screening visit.
- •Known history of drug or alcohol abuse.
- •Known history of HIV, hepatitis C or B virus (HCV or HBV)
- •Subjects with known Guillain Barré Syndrome in the past
- •2 or more hospitalization within the last year prior to screening visit
- •Increased liver enzymes 2.5 times above the upper reference level
- •Known hypersensitivity and/or allergy to any drugs
- •Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
- •Subjects who participated in another clinical study within 30 days prior to study entry
- •Subjects who are non-cooperative or unwilling to sign consent form.
- •Pregnant or lactating women at entry to study and those that are unwilling to agree to continue precautions for two months after completion of the study
研究组 & 干预措施
Adjuvanted Multimeric-001 500 Mcg
Adjuvant was montanide
干预措施: Adjuvanted Multimeric-001 500 Mcg (Biological)
Multimeric-001 250 Mcg
Multimeric-001 250 Mcg in PBS
干预措施: Adjuvanted Multimeric-001 250 Mcg (Biological)
Adjuvanted Multimeric-001 250 Mcg
250 Mcg in montanide
干预措施: Multimeric-001 250 Mcg (Biological)
Phosphate Buffered saline
Non-adjuvanted placebo
干预措施: Phosphate Buffered saline (Biological)
Adjuvanted PBS
Adjuvant was montanide
干预措施: Adjuvanted PBS (Biological)
Multimeric-001 500 Mcg
Multimeric-001 in PBS
干预措施: Multimeric-001 500 Mcg (Biological)
Multimeric-001 125 Mcg
Multimeric-001 in PBS
干预措施: Multimeric-001 125 Mcg (Biological)
结局指标
主要结局
Treatment-related Adverse Events
时间窗: Day 0 until day 42 (termination visit)
Number of treatment-related adverse events per cohort
Adverse Events
时间窗: day 0 until day 42 (termination visit)
Number of adverse events per cohort
次要结局
未报告次要终点